Expert review of neurotherapeutics
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Expert Rev Neurother · Dec 2013
Review Multicenter StudyClinical case reviews in multiple sclerosis spasticity: experiences from around Europe.
Spasticity is one of the main symptoms associated with multiple sclerosis (MS). Epidemiological studies indicate that approximately two-thirds of MS patients experience spasticity and, in a relevant proportion of this group, spasticity is moderate to severe. ⋯ This review of MS spasticity cases from around Europe presents current knowledge of considerations for administration of a new agent (tetrahydrocannabinol/cannabidiol-based nabiximols [Sativex®] oromucosal spray) for management of MS spasticity, with the aim of ensuring appropriate and optimal use for best outcomes. Assessment of the European clinical experience is intended to provide a better understanding of the prescribing regulations for MS spasticity treatments, facilitate identification of suitable candidate patients for Sativex and increase awareness of alternative management approaches for MS-related spasticity.
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Expert Rev Neurother · Feb 2012
Randomized Controlled Trial Multicenter StudyEfficacy and tolerability of combined dipyrone, isometheptene and caffeine in the treatment of mild-to-moderate primary headache episodes.
The efficacy and tolerability of a combination of dipyrone 600 mg, isometheptene 60 mg and caffeine 60 mg for the acute treatment of mild-to-moderate episodic primary headaches were evaluated against paracetamol 1000 mg and placebo. A total of 84 adult patients with two to six primary headache episodes (mild or moderate severity) per month were enrolled in this prospective, multicenter, randomized, two-period crossover study. Patients had a mean of 4.4 headache episodes/month (mean duration: 13 h; mean severity: 50.5 mm; assessed by visual analog scale (VAS). ⋯ Fewer patients required rescue medication after receiving combination therapy (18.4%), compared with paracetamol (37.7%; p = 0.008) or placebo (43.8%; p = 0.0007). Adverse events were infrequent and mild. We conclude that, despite failing to meet the primary outcome, the combination of dipyrone, isometheptene and caffeine is effective for the acute treatment of mild-to-moderate primary headache episodes, with excellent tolerability.
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Expert Rev Neurother · Feb 2011
Randomized Controlled Trial Multicenter StudyEfficacy and safety of ramelteon in Japanese adults with chronic insomnia: a randomized, double-blind, placebo-controlled study.
This randomized, double-blind, placebo-controlled study assessed the efficacy and safety of ramelteon 4 and 8 mg in Japanese adults with chronic insomnia. A secondary objective was to evaluate efficacy and safety when doses were uptitrated from placebo, ramelteon 4 and 8 mg to 4, 8 and 16 mg, respectively. Patient-reported sleep data were collected using sleep diaries. ⋯ Significant improvement was observed in the change in subjective total sleep time with ramelteon 8 mg at week 1. In post hoc analyses, ramelteon 8 mg reduced sSL in individuals with smaller fluctuations (within ±30 min) of sSL at baseline, in those with a shorter (<1 year) history of insomnia and in individuals who had not used benzodiazepines. Ramelteon up to 16 mg nightly was safe and well tolerated.